BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    BRDH

    Reg #: 3017196117 · FEI: 3017196117 · Expires 2026
    View on FDA
    Products
    32
    Proprietary Names
    86
    Establishment Types
    2
    Classifications
    32

    Registration Details

    Registration Name
    BRDH
    Registration Number
    3017196117
    FEI Number
    3017196117
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Burgemeester van Wageningenlaan 35
    City
    Roden Drenthe
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K090470
    PMA Number
    P010013

    Owner / Operator

    Firm Name
    BRDH
    Operator Number
    10076038
    Address
    Burgemeester van Wageningenlaan 35
    City
    Roden
    State
    Drenthe
    Postal Code
    9301 BS
    Country
    NL
    Correspondent
    Maria Ubels

    US Agent

    Business Name
    FDAbasics
    Contact Name
    Emily Matorin
    Address
    1 Prospect Park W Ste 4d Brooklyn Ny 11215
    City
    Brooklyn
    State
    NY
    ZIP
    11215
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Endoscopic Tissue Approximation Device OCW
    Staple, Implantable GDW
    Applier, Surgical, Clip GDO
    Clip, Implantable FZP
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed NUJ
    Screw, Fixation, Bone HWC
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Laparoscope, General & Plastic Surgery GCJ
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Instrument, Manual, Surgical, General Use MDM
    Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment HSZ
    Stapler, Surgical GAG
    Device, Thermal Ablation, Endometrial MNB
    Instrument, Ultrasonic Surgical LFL
    Washer, Bolt Nut HTN
    Staple, Fixation, Bone JDR
    Suture, Nonabsorbable, Synthetic, Polyamide GAR
    Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile GAQ
    Suture, Nonabsorbable, Silk GAP
    Suture, Absorbable, Natural GAL
    Suture, Nonabsorbable, Synthetic, Polypropylene GAW
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects OXJ
    Mesh, Surgical, Polymeric FTL
    Arthroscope HRX
    Orthopedic Manual Surgical Instrument LXH
    Accessories, Arthroscopic NBH

    Proprietary Names

    174006 176630 AR-8928BC-CP AR-1678-CP LF1837 Covidien LF1937 LF1923 EL5ML LS1020 LF1937 AR-1530BC 173022 00-8800-000-10 AR-7234 EGIA45AVM EGIAUSTND EGIA45AMT EGIA60AXT EGIA45AXT EGIA60AMT EGIA30AMT Endo Gia 30449 AR-2923PS AR-13995N AR-7237-7 AR-7237-7T AR-1204AS-90 TRIEEA31XT TRIEEA28MT ATS45 NS2013 GCS40G HARH36 HARH23 AR-2271 SIG45CTAVM SIG30CTAVM SIG45AXT SIG60AXT SIG30AMT SIG30AVM SIGTRS45AMT 72202467 72202468 212133 AR-2600SBS-5 212034 AR-1928SF-45 AR-1318FT-40 72205324 MSM20 C0R50 LF4418 HAR9F 176647 AR-7200 72202674 AR-9821 AR-1662BC-7 1665G SYM2015 ONB5STF2C AR-8400OBE AR-8400EX AR-8350DS AR-8926SS 5DCS AR-1588RT EEA25 EEA31 EEA2835 EEA2535 EEA28 7208678 AR-4068-05SD-1 ER420 AR-8979P-1 AR-8978DS-01 AR-7233 LS1500 OMS-PDB1000 TA3048S GIA80XTC AR-1324HF AR-2324PSLM lf1644

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device